Applying AAMI Standards to Real-World SPDs

Applying AAMI Standards to Real-World SPDs

By Jennifer Schraag

ICT takes a roundtable approach in examining the challenges and ensuing implications of applying AAMI standards in todays production-driven SPDs.

The Association for the Advancement of Medical Instrumentation (AAMI) has been at the forefront of developing standards for proper sterilization procedures for more than three decades, but just how well are AAMIs standards addressing real-world sterile processing departments (SPDs), and are these standards truly practical and doable? We asked some industry experts their opinion on the topic.

In my opinion, Id say were doing an excellent job as far as producing documents that are becoming our American national standards for end users to follow, says Chuck Hughes, general manager/educator with SPS Medical Supply Corp. Hughes currently serves on 10 AAMI sterilization working group committees. I think they are very practical and thats reinforced by the end users that are involved with the AAMI standards and contribute aggressively to the documentation.

Speaking of being involved, Linda Clement, BSM, CRST, consulting service manager of STERIS Corp., says AAMI would benefit highly from more such participation. I think the AAMI committee members who work on the user documents do a great job focusing on the real world challenges in sterile processing. Although I think the working groups could greatly benefit from more user participation actual SPD managers, technicians, etc. There is a small number of users who work in healthcare institutions and consistently attend and participate in the meetings, she states.

Hughes says another issue involving the standards and its ensuing compliance has to do with getting the word out. Were doing a horrible job getting that information out to users, he says. Not everyone can attend a conference or a seminar. How are we going to be able to reach those people who work in the trenches? Those people who come to work everyday and are good hardworking individuals, but cannot leave their facility for this kind of information. That really is going to continue to be a challenge over the next years in our industry.

Do you notice any particular areas of widespread noncompliance of the AAMI standards? Are there any you feel may have a higher compliance rate than others?

In consulting with SPD and operating room (OR) AAMI standards, I have observed the physical environment in SPD areas and flash sterilization in the OR. In the SPD space is rarely adequate. Temperature and humidity levels are frequently outside acceptable ranges, ventilation and airflow are not within recommended practice guidelines, and workflow is often inefficient. These issues are primarily a result of poor department design and lack of awareness by facility management of the types of services provided by the department and the volume of items they process. Flash sterilization in the OR is over used and improperly monitored with biological and chemical indicators. In addition, record-keeping has often been poor or non-existent. However, in the past few years I have seen much improvement in compliance with the use of personal protective equipment (PPE) and sterilization monitoring and recordkeeping in SPDs.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

Quite a few. Its rare for a facility to receive an extremely high grade from us in terms of full compliance. Generally what we find is that the supervisor that is in charge of the department may be thinking that certain aspects are being followed within the department, when in fact people are people and they tend to take shortcuts. So, sometimes there is a difference between shifts or there certainly can be a difference between facilities.

Chuck Hughes, general manager/ educator, SPS Medical Supply Corp. and AAMI committee member

In terms of compliance and how well the users are going to comply with AAMI really depends on education and how well they know the standards and whether the standards make sense in the real world.

Marcia Frieze, CEO, Case Medical and AAMI committee member

Do SPDs commonly have the proper materials to uphold the AAMI standards or are financial constraints inhibiting absolute compliance?

Many SPDs do not have current copies of AAMI standards or other valuable educational or reference materials in their departments. In addition, SPDs, although extremely important to a hospital, are still often overlooked when it comes to requests for equipment, materials, or human resources. They offer critical support to the largest revenue producing department in the hospital the OR. However, they usually are not high on the priority list when it comes to allocating financial resources. Without adequate financial support, compliance can be prohibitive.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

I think they have the resources, its just a matter of knowledge and discipline. Once the information is there, its a matter of discipline on whether or not that information is adhered to. Id say in general we do a poor job. Theres a long way to go. Many hospitals, were delighted to see their adherence, but there are healthcare facilities that are out there that seem to not be paying attention as well.

Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member

Everywhere I have worked, and particularly at St. Josephs, the materials for compliance are readily available. In my previous experience there have been some facilities that lack the appropriate supervisory personnel to adequately maintain absolute compliance among all staff members which is why we have a supervisor available for all shifts and relief lead technicians for those times when we [the supervisors] are not available.

David John Martin Jr., CRCST, sterile processing evening shift supervisor, St Josephs Hospital and Medical Center

Are facilities keeping up with revisions of the standards? Do you find this to be another possible financial constraint?

No. Of the hospitals I have consulted with over the past few years, some have never heard of AAMI, others have outdated standards, and few have current standards available in their departments. I think this issue is a combination of lack of awareness and information, and a lack of financial resources.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

Its a combination of things. Theyre not budgeting for the purchase of these materials and somehow, somewhere, theyre using a few hundred dollars as an excuse not to purchase them. I still feel it is simply they do not have the information and that this information is not something that is completely understood. We do an awful lot of seminars on the AAMI standards and what were trying to do is to clarify them or help them to interpret their meaning. One of the things that AAMI complains about is the fact that the information doesnt get out there, people arent ordering them, but at the same time I think there is a better marketing job that needs to be done, and letting people know there are standards for their specific area. Right now were in the middle of a major update for sterilization. Customers tend to get somewhat stalled. They dont know whether to purchase the current standards or to wait six months to a year to purchase the new standards. That is a bit problematic for the industry.

Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member

What area(s) may be the most challenging of the standards for SPDs to maintain and control compliance?

The most challenging area is processing loaner orthopedic total joint replacement instruments and other complex medical devices. The orthopedic instrument sets are extremely heavy and are difficult to dry. These sets dont always arrive in the SPD in a timely way to provide adequate processing time, which can pressure SPD staff members to cut corners during processing. They also have difficulty acquiring sterilization validation documentation from the manufacturer. As surgical technology continues to evolve, more and more complex medical devices are being manufactured and some of these devices are extremely difficult to clean or verify their cleanliness.

Additional challenges to standards compliance are:

  • Instructions for processing these types of devices can be difficult to acquire from the manufacturer.
  • Representatives from the SPD are rarely included in the purchase planning process to evaluate processing needs and to ensure that available processes and sterilization technologies are available to process these devices.
  • Thorough product/device trials are not always conducted prior to purchasing a new device.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

I think hospitals are probably doing a good job of informing what the policies and procedures are, but they seem to not have the resources to police them or to inspect they are indeed not being done properly. Of course, in some cases, it is very challenging. To quote a good friend of mine, Were trying to educate a parade. SPDs have the burden of not necessarily having a stable workforce, so youre always getting new people and trying to teach them proper policies and procedures to inform them and then inspect that theyve actually followed those procedures it is an ongoing challenge.

Chuck Hughes, general manager/ educator, SPS Medical Supply Corp. and AAMI committee member

What specific steps can managers take to ensure AAMI compliance?

Managers should ensure that they have a copy of the most current AAMI standards in their department and review them routinely. For new managers with little or no sterile processing experience, national CS professional organizations and their local chapter affiliates can provide valuable educational materials and certification programs to assist in acquiring basic and ongoing knowledge of sterile processing practices. Vendors also provide a wide variety of educational offerings from educational videos, self-paced study guides, clinical support, consulting services, and regional seminars to support best practices and standards compliance.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

Get out of their office. Manage by wandering around. Sometimes its good to get out and stir the pot and look over peoples shoulders and ask them questions. Nothing in my opinion takes the place of management by wandering around and jumping in and doing hands-on with the staff and observing first hand. As managers and supervisors, we inform but are we inspecting? The old expression, seeing is believing, still applies in this environment.

Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member

Be involved! Schedule time to work with the staff regularly. Our management team recognizes the strengths and the areas for improvement in all of our staff members and our processes. We use mistakes made as opportunities for growth and awareness, not for punishment. It is amazing to see the difference this makes in productivity and in the staff making their own decision to do the right thing. If you are on a level playing field, and you remove the fear, you will have more open communication with your staff and they will be much more comfortable sharing the truth of what is going on in your department. We have found that celebrating honesty, not punishing it, provides us with more effective avenues for educating our staff. If there is ever a time that blatant disregard for compliance is found or an employee is found to be negligent, the individual is put on a comprehensive development plan of action. Adequate supervisory staff is always essential.

David John Martin Jr., CRCST, sterile processing evening shift supervisor, St Josephs Hospital and Medical Center

What measures can regularly be taken in educating staff on the standards?

AAMI standards review should be incorporated into routine department educational programs. In doing this, all staff members receive consistent and current information regarding standards and this can also be used as a good tool for department self-assessment of current work practices.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

Have routine educational programs. The more compliant facilities that I visit actually make time on a weekly basis to in-service. Inservices on a monthly, or even on a weekly, basis should not be limited to just product inservices, but should include specific standards and servicing. Thats something thats not been readily available.

Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member

What can be done to ensure all staff is abiding by PPE standards?

Ive seen tremendous improvement in staff compliance with wearing PPE. The most common issue is the availability of appropriate, quality PPE in decontamination areas. The PPE purchasing decision-making process should not only be cost. PPE must be adequate to ensure the safety of staff members performing decontamination activities. I think focusing on educating staff members on the importance of PPE in the workplace and the OSHA standards regarding standard precautions has also increased safety awareness and compliance among SPD personnel.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

I used to hear from supervisors I just cant get Mary to do it right. OSHA changed that its a violation of federal law if healthcare facilities personnel in high risk areas do not provide proper PPE and ensure that it is used properly. I think today, the enforcement of proper use of PPE is clearly there. Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member First, educate! Then monitor compliance regularly and re-educate if necessary. Last, if noncompliance is an issue for an individual employee they need to be disciplined using a comprehensive development plan that outlines what the questionable behavior is, what the appropriate performance/behavior expectation is, and an opportunity for the employee to determine the best plan of action for themselves to attain the desired behavior/performance objective. People succeed much more often when they get to make their own decisions as to how to best accomplish a behavior/ performance goal.

David John Martin Jr., CRCST, sterile processing evening shift supervisor, St Josephs Hospital and Medical Center

How can managers ensure their staff isnt cutting corners when the lengthy processes required by the standards go against the requirement of staff to be highly productive?

This can be a tall order for SPD managers who work diligently to comply with standards and recommended practices on a daily basis. Developing a good working relationship with their hospital infection control practitioner (ICP) is a good place to begin. ICPs can be invaluable allies and champions for the SPD when it comes to fighting these types of battles with the many internal customers that SPDs have, such as the OR staff, who also struggle with a busy surgery schedule, unreasonable room turnover expectations, demanding surgeons, and insufficient inventories of surgical instruments.

Linda Clement, BSM, CRST, consulting service manager, STERIS Corp.

We have increased our dry time from the 20 minute standard to 40 minutes to accommodate the density of the larger consignment trays. We run a rapid readout biological monitor with every steam load to ensure the performance of each sterilizing cycle and thus assuring the sterility of each load sterilized. Recommended practice is once a week and with each load of implants. We use the STERIS sterilant to decontaminate our fiber optics and heat/pressure sensitive items. The standard suggested is the use of a high-level disinfectant.

David John Martin Jr., CRCST, sterile processing evening shift supervisor, St Josephs Hospital and Medical Center

Are there any other common concerns related to compliance with AAMI standards in SPDs?

Its been in the AAMI standards for quite some time and will continue to be in the standards that SPD personnel be certified both at the staff and management level and its unfortunate that a lot of the industry is waiting for the states to pass it as a law. I really believe the answer is to simply make that a policy or requirement in each institution and not wait for big brother to look over your shoulder and tell you to do the right thing.

Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member

Our industry is faced with more challenges than it ever had, like heavy sets, devices with lumens, power equipment, and robotic devices. The mission of AAMI was to focus on the science of sterilization and of setting standards for sterilizing these newer complex and challenging devices. If we dont address the challenge of sterilization and decontamination at AAMI, the healthcare community will not have guidance and realistic standards to follow. I think the beauty of AAMI is that it brings manufacturers and users together, and people from the scientific community. We may disagree and come with different perspectives, but in the end there is consensus and everyone comes to a decision that is in the best interest of the patient.

Marcia Frieze, CEO, Case Medical and AAMI committee member

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